COVID-19 PneumoniaPhase 2HOPENCT04315987
NestaCell® Mesenchymal Stem Cell to Treat Patients With Severe COVID-19 Pneumonia
A Phase 2 study testing NestaCell® in people with COVID-19 Pneumonia, run by Azidus Brasil at 4 sites in Brazil.
Trial summary
This is phase II study to assess the efficacy of NestaCell® (mesenchymal stem cell) to treat severe COVID-19 pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- NestaCell®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 4 sitesBrazil
- Study dates
- 30 Jun 2020to 28 Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female, aged ≥ 18 years 2. Present a confirmed or pending diagnosis of COVID-19, but with tomographic and clinical signs strongly suggestive of SARS-CoV-2 infection (COVID-19), with pulmonary impairment greater than or equal to 50% and: i. Oxygen saturation <95%; ii. CURB-65 rating ≥ a 4; d) Participants with a score on WHO ordinal scale that measures illness severity over time equal to 5 (Hospitalized with non-invasive ventilation or high-flow oxygen).
Who cannot join
- Patients with autoimmune diseases in the past or screening;
- Those who have serious basic diseases that affect their survival, including: malignant tumor, hematopathy, malignant fluid, active hemorrhage, severe malnutrition, etc. which have not been controlled and can not be removed due to multiple metastasis;
- Known or self-reported HIV or syphilis infected persons;
- Have participated in stem cell clinical research;
- Pregnant or lactating women or those who have fertility plans in the past year;
- The estimated life cycle is less than 48 hours;
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- Other conditions that the researcher thinks are not suitable for participating in the experiment.
- Shock
- Continuous use of immunosuppressive agents or organ transplants in the past 6 months;
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Hospital Vera Cruz
Campinas, São Paulo
Hospital de Barueri
São Paulo
IncCOR
São Paulo
UNIFESP
São Paulo
About this study
Official title: Exploratory Clinical Study to Assess the Efficacy of NestaCell® Mesenchymal Stem Cell to Treat Patients With Severe COVID-19 Pneumonia
This is phase II study to assess the efficacy of NestaCell® (mesenchymal stem cell) to treat severe COVID-19 pneumonia.
Read the detailed description
The number of infections of COVID-19 worldwide has killed thousands and is continually rising. The novel coronavirus attacks the human body by attaching to the angiotensin-converting enzyme-2 (ACE2), a protective enzyme against lung damage. In addition, the cellular serine protease TMPRSS2 for HCoV-19 Spike protein priming is also essential for the host cell entry and spread. Coronaviruses can be deadly, in large part because they cause "cytokine storms." These storms result from imbalances between pro-inflammatory and anti-inflammatory proteins called cytokines, which can cause extreme inflammation and respiratory complications. Respiratory distress kills hundreds of thousands of people each year worldwide, and hundreds of clinical trials are testing drugs to treat it.
MSCs have been widely used in cell-based therapy, from basic research to clinical trials Safety and effectiveness have been clearly documented in many clinical trials, especially in the immune-mediated inflammatory diseases.
NestaCell® is a mesenchymal stem cell therapy produced by Cellavita and proved to be safe in previous clinical trials.
The aim of this study is assess the efficacy of NestCell® as an add-on therapy to standard treatment to treat patients with severe COVID-19 pneumonia. .
Patients included will be randomized to receive 2x10^7 cells (20 million cells) on days 1, 3, 5 and 7.
- Conditions
- COVID-19 Pneumonia
- Being tested
- NestaCell®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NestaCell®Biological
Also called Mesenchymal Stem Cell
A dose of 2x10^7 cells (20 million cells) will be administered IV on days 1, 3, 5 and 7 in all subjects.
PlaceboBiological
Matching Placebo will be administered IV on days 1, 3, 5 and 7 in all subjects.
| Study group | Role | What they receive |
|---|---|---|
| NestaCell® | Experimental | A dose of 2x10^7 cells (20 million cells) will be administered IV on days 1, 3, 5 and 7 in all subjects. Receives: Biological: NestaCell® |
| Placebo | Placebo comparator | Matching placebo will be administered IV on days 1, 3, 5 and 7 in all subjects. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Condition
Ordinal scale (WHO ordinal scale that measures illness severity over time)
Measured: 10 days
Secondary outcomes (8)
Rate of mortality within 10-days
Evaluation of Pneumonia change
Measured: 10 days
Change of Clinical symptoms - respiratory rate
Evaluation of Pneumonia change
Measured: 10 days
Hypoxia
oxygen saturation
Measured: 10 days
PaO2 / FiO2 ratio
oxygen saturation
Measured: 10 days
CD4+ and CD8+ T cell count
Marker of Immunological function
Measured: Days 1, 2, 4, 6 and 8.
Changes of blood oxygen
PaO2 / FiO2 ratio
Measured: 10 days
Side effects in the treatment group
Number of participants with treatment-related adverse events
Measured: 10 days
Complete blood count, cardiac, hepatic and renal profiles;
Complete blood count, ALT, AST, GGT, CK, CKmB and creatinine
Measured: Days 1, 2, 4, 6 and 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start30 Jun 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized (1:1) to receive NestaCell (n=45) or Placebo (n=45).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cellavita Pesquisa Científica Ltda, Hospital Vera Cruz
- Responsible party
- Sponsor
- Investigators
- Florentino de Araujo Cardoso Filho, Principal investigator, Hospital Vera Cruz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315987
- Sponsor's protocol ID
- HOPE
- Acronym
- HOPE
- Status last verified
- Oct 2022
- First submitted
- 18 Mar 2020
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study to Assess the Efficacy of NestaCell® Mesenchymal Stem Cell to Treat Patients With Severe COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04315987
- Acronym / sponsor ID
- HOPE / HOPE
- Conditions
- COVID-19 Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Collaborators
- Cellavita Pesquisa Científica Ltda, Hospital Vera Cruz
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is phase II study to assess the efficacy of NestaCell® (mesenchymal stem cell) to treat severe COVID-19 pneumonia.
Detailed description
The number of infections of COVID-19 worldwide has killed thousands and is continually rising. The novel coronavirus attacks the human body by attaching to the angiotensin-converting enzyme-2 (ACE2), a protective enzyme against lung damage. In addition, the cellular serine protease TMPRSS2 for HCoV-19 Spike protein priming is also essential for the host cell entry and spread. Coronaviruses can be deadly, in large part because they cause "cytokine storms." These storms result from imbalances between pro-inflammatory and anti-inflammatory proteins called cytokines, which can cause extreme inflammation and respiratory complications. Respiratory distress kills hundreds of thousands of people each year worldwide, and hundreds of clinical trials are testing drugs to treat it.
MSCs have been widely used in cell-based therapy, from basic research to clinical trials Safety and effectiveness have been clearly documented in many clinical trials, especially in the immune-mediated inflammatory diseases.
NestaCell® is a mesenchymal stem cell therapy produced by Cellavita and proved to be safe in previous clinical trials.
The aim of this study is assess the efficacy of NestCell® as an add-on therapy to standard treatment to treat patients with severe COVID-19 pneumonia. .
Patients included will be randomized to receive 2x10^7 cells (20 million cells) on days 1, 3, 5 and 7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized (1:1) to receive NestaCell (n=45) or Placebo (n=45).
| Arm | Type | Receives |
|---|---|---|
| NestaCell® | Experimental | Biological: NestaCell®A dose of 2x10^7 cells (20 million cells) will be administered IV on days 1, 3, 5 and 7 in all subjects. |
| Placebo | Placebo comparator | Biological: PlaceboMatching placebo will be administered IV on days 1, 3, 5 and 7 in all subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Male or female, aged ≥ 18 years 2. Present a confirmed or pending diagnosis of COVID-19, but with tomographic and clinical signs strongly suggestive of SARS-CoV-2 infection (COVID-19), with pulmonary impairment greater than or equal to 50% and: i. Oxygen saturation <95%; ii. CURB-65 rating ≥ a 4; d) Participants with a score on WHO ordinal scale that measures illness severity over time equal to 5 (Hospitalized with non-invasive ventilation or high-flow oxygen).
Key exclusion criteria (9 listed)
- Patients with autoimmune diseases in the past or screening;
- Those who have serious basic diseases that affect their survival, including: malignant tumor, hematopathy, malignant fluid, active hemorrhage, severe malnutrition, etc. which have not been controlled and can not be removed due to multiple metastasis;
- Known or self-reported HIV or syphilis infected persons;
- Have participated in stem cell clinical research;
- Pregnant or lactating women or those who have fertility plans in the past year;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NestaCell®Also: Mesenchymal Stem CellA dose of 2x10^7 cells (20 million cells) will be administered IV on days 1, 3, 5 and 7 in all subjects. | Biological | NestaCell® |
| PlaceboMatching Placebo will be administered IV on days 1, 3, 5 and 7 in all subjects. | Biological | Placebo |
Primary outcome
Change in Clinical Condition
Time frame: 10 days
Ordinal scale (WHO ordinal scale that measures illness severity over time)
8 secondary outcomes
Rate of mortality within 10-days
Time frame: 10 days
Change of Clinical symptoms - respiratory rate
Time frame: 10 days
Hypoxia
Time frame: 10 days
PaO2 / FiO2 ratio
Time frame: 10 days
CD4+ and CD8+ T cell count
Time frame: Days 1, 2, 4, 6 and 8.
Changes of blood oxygen
Time frame: 10 days
Side effects in the treatment group
Time frame: 10 days
Complete blood count, cardiac, hepatic and renal profiles;
Time frame: Days 1, 2, 4, 6 and 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: Undecided. It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florentino de Araujo Cardoso Filho principal investigator
Hospital Vera Cruz
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NestaCell® in people with COVID-19 Pneumonia, run by Azidus Brasil at 4 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Condition (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.